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CHAPTER TWENTY-TWO

Mode of operation

134

Mode of operation

22.1.4  

Specificity

 

The specificity of an ABR hearing screening instrument quantifies the ability 

of the device to identify ears with normal hearing (the true negative rate). 

When there is no hearing loss we can assume that an ABR is present. 

Specificity is therefore the probability of a ‘Valid ABR’ (pass) result when 

an ABR is truly present. In practice ABR screening test specificity is 

dependent on both the amplitude of individuals ABR at the electrodes and 

the levels of noise occurring during the test. Both vary according to the 

individual, electrode connection, position, resting state of the infant and the 

environmental noise.  The mean amplitudes of ABR from 270 infant was 

determined from healthy normally hearing baby’s ABR recorded by the 

Otocheck ABR using our short chirp stimulus at a level of 35dBnHL and a 

rate of 52 per second. The normal distribution (spread) of ABR amplitudes 

was determined from an historical study of 3200 infant ABR recordings 

at 30dBHL*, in particular the probability of small ABR amplitudes from 

normal ears.  The noise levels recorded by the Otocheck ABR instrument 

during tests when the baby was quiet, were averaged. The probability of 

the Otocheck ABR normal ABR amplitudes, including the weakest normal 

ABRs, against fluctuating noise of the average amplitude in ‘quiet babies’ 

was determined to be as below:

All Pass Criteria

Pass probability (%)

99.70

CI(Hi) (%)

99.75

CI(Low) (%)

99.59

Specificity 

99.79%

 

Important Notes:

•  High EEG, myogenic or powerline noise levels can greatly 

reduce specificity.

•  Testing with active infants will reduce specificity, depending on 

the movement noise.

•  Testing with higher stimulus levels will increase specificity 

because the response will be larger but will reduce the range 

of threshold elevations to which the instrument is sensitive 

(according to the stimulus dBnHL used).  

Содержание Otocheck ABR

Страница 1: ...Otocheck ABR Issue 4 Otocheck ABR User Manual...

Страница 2: ...ards Doc Ref MANABR4 4 Copyright Notice No part of this publication may be copied by any means translated or distributed to third parties without the express written permission of Otodynamics Ltd Copy...

Страница 3: ...2 Optional accessories 15 2 3 Controls indicators and connections 16 2 4 Labelling 17 3 Getting started 19 3 1 Connecting probes and electrodes 19 3 2 Initial charge 22 3 3 Using the keys and keypad 2...

Страница 4: ...al hearing 38 7 ABR test 39 7 1 Impedance check 40 7 2 Checkfit 44 7 3 Ear cup Checkfit 46 7 4 ABR test 47 7 5 Quick Save option 54 7 6 Review 55 7 7 Save 56 8 Worklist 59 8 1 Adding Patients 59 8 2 T...

Страница 5: ...nter 93 11 9 Changing the battery 94 12 Scanning 95 12 1 Scanning facility 95 12 2 Scanner types 95 12 3 When to use the scanners 97 13 Quality tests 99 13 1 Probe test 99 13 2 ABR cable test 104 13 3...

Страница 6: ...uipment troubleshooting 124 18 1 Otocheck lock up 124 18 2 Switch on 124 18 3 System details 124 18 4 Instrument fault message 125 18 5 Hardware fault messages 126 19 Training 127 20 Obtaining service...

Страница 7: ...for use with infants The ABR screening function uses conventional Fsp methodology to detect the response supported by waveform identification Template Correlation which is optimised for infants from 3...

Страница 8: ...it is not recommended that tests be allowed to continue indefinitely even if there is no result The Otocheck includes stop criteria which will automatically terminate the test when an ABR pass has bee...

Страница 9: ...ocked microphone tube will prevent the Otocheck from sensing the stimulus level in the ear As a result the Otocheck may apply a louder than normal sound to the ear All surfaces of the Otocheck may be...

Страница 10: ...monly known as auditory evoked potentials A response which occurs within 20ms of the onset of the stimulus is referred to as an Auditory Brainstem Responses ABR As the amplitude of the ABR is very sma...

Страница 11: ...fication 2 Equipment identification 2 1 Supplied in Otocheck ABR kit Otocheck ABR REF ABR EC1 Electrode cables 1m REF ABR EC2 Electrode cables 2m REF ABR SK Starter kit of electrodes skin preparation...

Страница 12: ...entification 12 Equipment identification REF ABR CAV Probe cavity and ABR cable tester REF PR CLIP Probe cable clip REF PR POUCH Drawstring probe pouch Re order quantity 10 REF PR UGS UGS probe REF OA...

Страница 13: ...ABR CAS Equipment case for Otocheck ABR kit TPC probe coupler tubes x 5 See chapter 15 for fitting instructions Re order codes REF TPC 10 quantity 10 REF TPC 100 quantity 100 REF BGS BGS probe body an...

Страница 14: ...ntification 14 Equipment identification REF OTOLINK Otolink software CD Documentation pack Includes instrument and software manuals quickstart and probe use guides REF OP CAB PC downoad cable REF OP C...

Страница 15: ...ABR User Manual 15 Equipment identification 2 2 Optional accessories REF OMP R Otocheck printer Wireless printing REF ABR CUP Ear cups Optional accessory for ABR screening as an alternative to direct...

Страница 16: ...ets and electrode sockets Impedance check indicator LEDs Quick release clips Otoport Lite controls and keypad USB PSU connected and battery charging indicator LEDs Charger PC cable socket Menu selecti...

Страница 17: ...l 17 Equipment identification 2 4 Labelling 2 4 1 Symbols The label uses the following symbols DC Caution Refer to user manual Class II electrical protection double insulated Type BF applied part Manu...

Страница 18: ...cs Item reference Otocheck ABR Screener 11 Production date 31st January 2015 21 Serial numbers 1234 Otoport 1234 ABR 240 Additional product ID BRT used to identify any hardware modules fitted 250 Seco...

Страница 19: ...ting started 3 1 Connecting probes and electrodes The connections panel for probes and electrodes is found at the top end of the module 3 1 1 Connecting the probe The probe plug contains a key that mu...

Страница 20: ...the knurled sleeve in a clockwise direction until finger tight 3 1 2 Disconnecting the probe To disconnect the probe unscrew the knurled sleeve in an anticlockwise direction until the thread is diseng...

Страница 21: ...ectrodes that are terminated with 1 5mm Touchproof DIN 42 802 connectors may be used Carefully align the electrode connector plug with the appropriate electrode socket observe colour coding and then p...

Страница 22: ...a circle enable you to execute the functions offered on the screens Their functions vary from screen to screen but generally the right circle key provides affirmative options and the left square key p...

Страница 23: ...d first then lower case then numbers e g ABCabc2 For subsequent characters lower case is shown first e g abcABC2 More characters can be stored than can be displayed on the screen Arrows are displayed...

Страница 24: ...the date displayed or Cancel to ignore the changes If the date has not been edited it will remain as dd Mmm yyyy by default For Date of Birth entry D O B the Otocheck will not permit entry of a futur...

Страница 25: ...econds following any key press and remains on during testing The backlight can be configured see chapter 10 Configuration 3 3 9 Stimulus and Noise OK indicators blue LEDs The two blue LEDs above the s...

Страница 26: ...the keypad The display screen will show Switch Unit On Select Yes to confirm Otocheck switch on or No to turn the unit off again If Yes or No are not selected within two seconds of pressing the on off...

Страница 27: ...ppear to the right of the logo to provide an indication of the Battery Power remaining Please refer to chapter 18 Power for battery information A prompt will be shown if the Otocheck is due to be cali...

Страница 28: ...is selected use the data entry keypad to enter a corresponding Password if required for that user To improve security during Login a symbol will replace each character as it is entered in the Password...

Страница 29: ...the main menu screen From here you can view the Result of the last test select the Last patient tested or perform a Test ABRcustom only available if configured see chapter 10 Use the left and right a...

Страница 30: ...y discharge from the ear to be tested Choose a quiet room without background noises Ensure the patient is comfortable and settled Ensure you can clearly see the ear to be tested 5 2 Environment checks...

Страница 31: ...r and free from debris If debris subsequently enters the probe sound tubes do not attempt to clean them the coupler tubes should be changed The correct size tip will look slightly larger than the ear...

Страница 32: ...eft ear or 5 o clock for right ear Push the probe firmly into the ear canal at this angle Hold the probe for several seconds Then release the probe No discomfort should be felt by the patient The weig...

Страница 33: ...tely firm strokes in order to obtain a satisfactory connection to the skin Excessive caution with skin preparation can disturb the baby more than firmer strokes If using a wet prep use a gauze pad to...

Страница 34: ...ons avoid hair when possible When using wet gel electrodes the sticky area around the central gel should be pressed to the skin not the central area itself Shoulder common black and nape of neck negat...

Страница 35: ...is optimised for the electrode placements described above Alternative placements are possible including Recommended Alternative 1 Alternative 2 Positive Red High forehead High forehead High forehead N...

Страница 36: ...ly onto the electrodes if impedance is only slightly high 3 Remove and re prep the electrode site that has high impedance If that fails to work re prep all sites 4 If re prepping does not work try a f...

Страница 37: ...close to the heart front or back of the patient Noise can be generated by a large EKG response 4 Smooth and swaddle the baby in an effort to calm him her Note that electric muscle artefacts may arise...

Страница 38: ...ent in the room 3 Do not use mobile cellular phones when operating the equipment 4 Separate the electrode cables from the probe cable if intertwined 5 Move to a quieter location if possible 6 4 No res...

Страница 39: ...able and may differ if other cables are in use Connect the electrode leads and the probe to the ABR unit and prepare your patient Connect the red ve cable to the high forehead the white ve cable to th...

Страница 40: ...test conditions are good The ABR test will start automatically if the electrode impedances are good and the electrical noise EEG is low for a few moments If test conditions are moderately good If tes...

Страница 41: ...l not be possible to start a test manually A message on the screen will show the problem It will tell you if EEG Noise Powerline Noise or Impedance are preventing the test from starting Try to resolve...

Страница 42: ...More than 16 k Poor The green LED lights on the top of the ABR unit will be lit if the connection of the electrode closest to that light is optimum good or moderate Autostart requires that all impedan...

Страница 43: ...vices This level is high if there is a lot of interference from electrical noise and or one or more of the electrodes is poorly connected has high impedance If impedance levels are acceptable but the...

Страница 44: ...s shows a series of ears of increasing size indicating increasing ear canal volumes The size of ear canal detected in Checkfit is indicated by an arrow During Checkfit the Otocheck repeatedly plays a...

Страница 45: ...nal in an adult may occur because of wax blocking the canal Noise level indicator A Noise Level Indicator is shown on the right of the Checkfit screen The red green bar moves in response to changes in...

Страница 46: ...will be prompted with a message to confirm There will be three options Yes No and Checkfit Using the probe direct in a neonate ear will always create a small cavity but using large adult ears may trig...

Страница 47: ...ally when either the circle is filled there is a ABR response present when the blue NLO bar is filled a full set of data has been recorded but no response has been detected or when test noise ABR nois...

Страница 48: ...o NLo shows the number of sweeps accepted into the average NHi shows the number of sweeps rejected due to high electrical noise levels Accepted Shows the number of sweeps accepted into the average Rej...

Страница 49: ...clear response is present right disagreement between them shows the presence of noise left Excess noise may obscure an ABR The alternative waveforms are displayed in orange and yellow The average of...

Страница 50: ...tart 7 4 5 Pausing the test Select Pause to temporarily stop data collection You may wish to do this if the test environment worsens for example the subject becomes temporarily active an electrode bec...

Страница 51: ...e checkmark will be displayed The test result can be saved at this point or the results can be reviewed prior to saving If Review is selected three screens are available by using the left and right ar...

Страница 52: ...circumstances under which each result would be shown Test Result Description ABR Pass The data collected has met the pass criteria A clear ABR has been found Note Optimum pass criteria will depend on...

Страница 53: ...trical equipment prevented the test from passing The Fsp pass threshold was elevated due to this interference and the Fsp did not reach this higher threshold High Impedance The electrode impedances me...

Страница 54: ...o save to the right ear The test will be saved to the current patient or will be given an automatic ID and name This name and ID may be edited by selecting Last from the main menu screen If Automatic...

Страница 55: ...ck Save Off If Quick Save is Off select Save to skip to the Patient Details screen ready to Save Select Review to view the data of the completed test prior to saving Select Cancel to discard the test...

Страница 56: ...ossible to store different facilities for different patients If you wish to change the Facility download and erase all test records from the Otocheck first It is also not possible to set the NICU fiel...

Страница 57: ...forces the user to choose an ear before the test can be saved Press the right control key or the right arrow to select the Left Ear or press the left control key or the left arrow key to select the R...

Страница 58: ...ight Ear Save Test to Left Right Ear Again may appear on Save if the patient s previous test was saved to the same ear Select Yes to accept the current ear choice or No to return to the Select Ear scr...

Страница 59: ...y default but can be switched Off in the Config area see chapter 10 Access the Worklist by using the left or right navigation keys from the main menu 8 1 Adding Patients If the worklist already contai...

Страница 60: ...details Up to 50 patients may be added to the Worklist 8 2 Testing from the Worklist Scroll to the required patient Select Test to begin testing this patient When a test has been saved to a patient t...

Страница 61: ...ients Scroll to the required patient Select Delete to remove Select Yes to delete the selected patient from the Worklist Select All to delete all of the patients from the Worklist Select No to return...

Страница 62: ...may be erased from the Memory Status screen accessed from the Configuration area see chapter 10 Records also allows the user to select a previously tested patient for a new test Selecting Records fro...

Страница 63: ...the current patient is twelfth in a list of 34 patients Use the up and down arrow keys to scroll through the list one patient record at a time A selected patient will be shown as highlighted in the li...

Страница 64: ...st from this screen starts a new test the result of which will be saved with the records of the selected patient Selecting the up and down arrow keys on the patient details screen displays the patient...

Страница 65: ...that there are other saved test records for this patient The left and right arrow indicators display the Patient Details for this patient Select Print to print an individual test summary Select Back a...

Страница 66: ...ty Tests to check the performance of the probe or the ABR electrode cables Select Test Settings to change test display and pass criteria Select Date Time to set the current date and time Select System...

Страница 67: ...the probe and elecrode cable tests are in chapter 14 Quality tests 10 3 Test settings The Otocheck ABR has two different ABR test modes ABRscreen and ABRcustom ABRscreen is optimised for the screenin...

Страница 68: ...HL If Stim Level is set to OFF then the selected mode ABRscreen or ABRcustom is not available for testing and it will not appear in the main menu carousel The ABRscreen mode is intended for newborn he...

Страница 69: ...lus level 1dB steps are intended for the setting of precise custom stimulus levels e g for compatibility with prior screening practice Low stimulus levels down to 5dBnHL can be used for the audiologic...

Страница 70: ...staken for an ABR The minimum fixed Fsp threshold is higher than the largest Fsp ever likely to be achieved by chance in EEG noise The minimum TC requirement should be achieved when recording an ABR w...

Страница 71: ...is setting allows the use of ear cups and it can be set in three different ways OFF Will always go into test assuming ear cups are not being used AUTO Will detect whether ear cups are being used and p...

Страница 72: ...mulus level Stim Type is configurable only in ABRcustom default is chirp in both modes Start If Start is ON then the ABR test will proceed from the Impedance Check screen to data collection autostart...

Страница 73: ...users who are testing only babies The warning message is displayed after Checkfit and before the test starts Selecting Start will start the test as normal Checkfit returns the user to Checkfit Cancel...

Страница 74: ...ue to use the left and right arrow keys to jump between the Day Month Year and the up and down arrow keys to select the required date The date Format can be changed between dd Mmm yyyy and mm dd yyyy...

Страница 75: ...ng Erase deletes all test records from the Otocheck after requesting confirmation from the user A screen confirming the Erase is then displayed and the user is returned to the main menu If there is le...

Страница 76: ...changes and return to the Controls Menu Brightness The screen Brightness can be altered by pressing the left right arrow keys Select Save to accept the adjusted Brightness level Select Cancel to ignor...

Страница 77: ...raphic on the right of the screen conveys the total remaining battery power The battery segments are shaded according to the following criteria Segments Displayed Battery Power 7 95 100 6 75 94 5 55 7...

Страница 78: ...o PC Load then the Otocheck can use Bluetooth communication to send test results to a PC Details of how to set up wireless download to PC are included in your Otolink manual If Bluetooth is set to Pri...

Страница 79: ...ancel to discard any change Note To avoid printout duplication it is not possible to set Auto Send to On and End Data to Patient Print If Print is set to Automatic then the test result is automaticall...

Страница 80: ...All unprinted tests Printing will only start if the Otocheck is on and displaying one of the main module screens see section 4 4 If Cancel is selected during the print three options are available If...

Страница 81: ...identification and mode of operation The firmware revision number and issue date is stated together with the unit s unique hardware ID The next scheduled Calibration Due date is also shown A dash is s...

Страница 82: ...only optional Admin Select Yes to give the new N A user administrator rights Select No to restrict the user N A to screener rights The User ID is added to a saved test record to identify the user who...

Страница 83: ...ils of a highlighted user Select Save to save changes to the user s details and return to the User List Select Delete to remove the selected user from the User List A confirmation message will appear...

Страница 84: ...available on Bluetooth enabled Otocheck ABR and Otoport instruments If a Bluetooth module is fitted a Bluetooth symbol shown above is included on the product label Downloading can also be performed w...

Страница 85: ...ructions When the connection to the PC is ready to send data the PC Load text on the Otocheck screen is green If the connection is not complete then the PC Load text on the Otocheck screen is black Bl...

Страница 86: ...an print and download The Otocheck provides flexible options as described on the following pages Print and PC Load settings are located under Configuration in System Setup Bluetooth must be set to Pri...

Страница 87: ...download when the test is saved see 10 5 4 Setup for details The test is saved and a print download initiated with one key push 11 3 3 Printing or downloading from records Results can be printed or do...

Страница 88: ...ferent tests for the patient using the up and down arrow keys and select Print or PC Load Select PC Load on the Records menu to download all new records for all patients and tests that haven t previou...

Страница 89: ...onnection to a single printer the last Otocheck to print must be switched off before another Otocheck can print The printer is powered from batteries or can be connected to mains power when printing P...

Страница 90: ...retry To retry the print ensure the printer is switched on and is within range 5m Then select Retry If printing wirelessly and you have an alternative printer available select Alter and the Otocheck w...

Страница 91: ...d spooled and printed when the detected condition is rectified The printer s green light will flash when a print job is being stored 11 6 Printer light summary The light at the front of the printer ha...

Страница 92: ...unt of paper from the roll Insert the new roll 2 ensuring the paper will pass through the paper feed 3 and close the cover with a click After loading check that the paper advances properly using the p...

Страница 93: ...A full charge will take approximately 15 hours Charger jack plug socket The printer can be used as normal whilst charging Once fully charged the printer has enough power for around 10 hours standby u...

Страница 94: ...ynamics To change the battery pack Remove the screw 1 from the battery compartment cover TRAINING REQUIRED Push down and slide back the battery compartment cover 2 Remove the old battery pack and disc...

Страница 95: ...ogin Each operator can be assigned a login card which the Otocheck will scan and verify in order to provide access to the machine 12 2 Scanner types The Otocheck has two scanning methods available 12...

Страница 96: ...ans radio frequency identification RFID chips which can hold enough alphanumeric data for a complete patient data record on the Otocheck To scan with the RFID scanner hold the card up to the Otocheck...

Страница 97: ...option will now change to Scan Select Scan to populate the patient details Make further edits manually with the keypad Then continue to either test or save the result as normal 12 3 2 Adding a patient...

Страница 98: ...for more details On the New user screen select Scan The RFID method can set all user parameters For barcode scanning the user name ID and password are automatically set but the other user parameters...

Страница 99: ...u 13 1 Probe test Probe Test is an option accessed from the configuration menu see chapter 10 Configuration A Probe Test should be performed regularly to monitor the calibration of the probe s output...

Страница 100: ...to its natural position and the shoulder may no longer touch the cavity Inserting the probe at the wrong angle or with the probe head over one of the screws may result in incorrect test results Selec...

Страница 101: ...e or more of the levels recorded are outside the absolute range specified for the probe If a Fail is shown on screen inspect the probe coupler tubes for debris replace the coupler if necessary and rep...

Страница 102: ...selecting Retest ensuring the ear piece is firmly inserted in the test cavity A Query result indicates that there have been changes in the probe but that these changes are not large enough to invalida...

Страница 103: ...e The NEW level only is highlighted The 1 2 and 4kHz values may not be stored in the probe if a new probe is being used with the system To save new data run a Probe Test record the values for each fre...

Страница 104: ...le Test and wait for the result to be displayed If the electrode cables are OK then a large tick is displayed on the screen If any of the cables fail the test a large cross is displayed Select Details...

Страница 105: ...s the cavity test has passed If the result Stopped Too Soon Too Noisy or Poor Probe Fit is achieved retest checking that the probe ear piece is firmly inserted into the test cavity and that the noise...

Страница 106: ...spare probe body lid See chapter 2 Equipment identification for details 14 2 Probe cable clip The probe cable clip is provided to aid the practical aspects of positioning and securing the probe cable...

Страница 107: ...t and release the plunger The position of the clip on the cable can be adjusted if necessary Open the crocodile clothing clip Attach the probe cable clip to the patient s clothing If the cable slips t...

Страница 108: ...Small newborns T5 5B REF T T5 5B Fits 5 5mm ear canal Most newborns T11M REF T T11M Fits 11mm ear canal Large adult ears T13M REF T T13M Fits 13mm ear canal Extra large adult ears T8M REF T T8M Fits 8...

Страница 109: ...aning fluid into the tubes The design of the tips for the UGS probe leaves a 0 5mm gap between the end of the coupler tubes and the end of the tip Therefore the tubes should never come into contact wi...

Страница 110: ...c wipes and dried with a tissue immediately afterwards Do not allow liquids to enter the sound tubes Coupler assembly Each coupler assembly has two sound tubes These are protected from ingress of fore...

Страница 111: ...obe fig 4 15 2 2 Reassembling the probe Fit the new coupler tubes to the probe assembly fig 1 Fit the outer shell figs 2 and 3 followed by the lid fig 4 Click the lid into place using firm finger pres...

Страница 112: ...Otodynamics disposable tip Use of a tip is essential Use without a tip will expose the ear canal to the hard plastic sound tubes and this might cause injury Use without a tip or with an incorrect or...

Страница 113: ...than the probe ear piece and cable the Otocheck hardware should not come into contact with the patient being tested Otodynamics probe tips are disposable and for single use only A new tip should be u...

Страница 114: ...aned if it becomes contaminated Clean surfaces of the Otocheck with an alcohol based sterile wipe or cloth and antiseptic fluid Dry the Otocheck with tissue immediately afterwards Do not allow liquid...

Страница 115: ...tery life depends on the Otocheck usage pattern With built in power save functions and by switching the device off for the periods between tests the battery will provide enough power for over a week s...

Страница 116: ...nd return to the previous screen displayed If the Otocheck is left for 20 minutes in standby it will turn off An audible beep will be emitted from the device for a period of 10 seconds to alert the us...

Страница 117: ...a battery indicator which displays the remaining level of battery charge The indicator has 5 segments which convey the total Battery Charge remaining The battery segments are shaded according to the f...

Страница 118: ...tery 17 4 2 Critical battery When the battery power reaches 7 remaining a Critical Battery warning message will appear on screen This equates to approximately 10 minutes of use Select OK to accept the...

Страница 119: ...to a PC Note Do not charge more than one Otocheck on the same PC at any one time 17 5 1 Connecting the Otocheck ABR to the charger cable Switch off the instrument prior to charging Connect the mains l...

Страница 120: ...up to 4 hours When the device is fully charged a large tick will appear on the screen 17 5 2 Charge indicator lights There are additional charge indicators on the side of the Otocheck ABR Power light...

Страница 121: ...s may be convenient if you wish to leave the device charging overnight 17 5 3 Disconnecting the Otocheck When the charging cable is disconnected the power light will extinguish on the Otocheck and if...

Страница 122: ...d then fully charging the device see chapter 10 Configuration The condition utility is available from the Configuration menu by selecting System then Battery Selecting Condition and confirming will se...

Страница 123: ...Otocheck ABR User Manual 123 Power 17 7 Additional battery care If the Otocheck is not in regular use in order to maintain the battery fully charge the device every two months...

Страница 124: ...nd complete its start up sequence check that it is charged and try again If the Otocheck still fails to complete its start up sequence then contact your dealer or Otodyamics for support 18 3 System de...

Страница 125: ...instrument fault the following message will be displayed at the start a test No stimulus will be delivered from the Otocheck probe and you will not be able to start a test Turn off the device and the...

Страница 126: ...then be turned on and off a number of times to ensure that the error doesn t reoccur If you receive the hardware fault message again contact your distributor or Otodynamics for support Error 2 The ab...

Страница 127: ...y Training in the UK is provided by Otodynamics Ltd Training elsewhere is via an approved dealer who has been trained by Otodynamics Training on ABRs and use of the equipment may also be provided by p...

Страница 128: ...nt to Otodynamics for service or repair please ensure all items particularly the instrument and probe are clean and free from contamination Otodynamics cannot guarantee the equipment will be contamina...

Страница 129: ...apter 13 to ensure the instrument is working correctly In addition to this the calibration of the instrument should be periodically checked with laboratory equipment Otodynamics advises regular calibr...

Страница 130: ...18 8ms Amplifier gain 75dB Amplifier CMRR 60dB at 100 Hz Input impedance 1M 10 nF Amplifier noise 20 nV Hz 0 1 1 kHz Input bandwidth 150 1000 kHz Notch filter None Impedance sense current 0 2 A Impeda...

Страница 131: ...The frequency dispersion of the chirp is defined by the delay at frequency T f k f d with k 0 0920 and d 0 4356 The wide band chirp waveform was cosine filtered in the time domain to give the require...

Страница 132: ...differing levels of EEG noise and power line interference in which the device can be used but without any ABR actually being present It is important to note that the measured sensitivity of an instrum...

Страница 133: ...a realistic wide range of neonate electrode noise signals i e from sleeping to restless is processed by the device As no acoustic stimulation actually reached the ear no real ABR was present so all pa...

Страница 134: ...imulus at a level of 35dBnHL and a rate of 52 per second The normal distribution spread of ABR amplitudes was determined from an historical study of 3200 infant ABR recordings at 30dBHL in particular...

Страница 135: ...ng with a click stimulus rather than our short chirp will slightly decrease specificity because click stimuli generate a slightly smaller ABR response than a chirp of identical hearing level due to re...

Страница 136: ...Electrode connectors compatible with 1 5mm Touchproof DIN 42 802 connectors Charging Data connector connects to Otodynamics PSU charging or to PC USB port USB 1 1or 2 0 via Data Cable Bluetooth wirel...

Страница 137: ...ous data collection Battery voltage operating range 3 4 2V Max consumption when testing 720mW Max consumption when charging 2 5W Source 1000mAh lithium polymer internal rechargeable cells Charge time...

Страница 138: ...uencies above 4kHz 23 1 11 Environmental Protect from heat and radioactive sources Keep dry Transport and storage Temperature range 0 to 40 Celsius Pressure 23KPa to 101KPa Humidity 10 to 90 non conde...

Страница 139: ...Collateral Standard Safety Requirements for Medical Electrical Systems BS EN 60601 1 2 Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compat...

Страница 140: ...lies buildings used for domestic Harmonic emissions Class A purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 23 2 Electromagnetic Compatibility Otocheck ABR The Oto...

Страница 141: ...kV differential Mains power quality should line s mode be that of a typical commercial or hospital IEC 61000 4 5 2 kV line s to 2kV common environment earth mode Voltage dips 5 UT 5 UT Mains power qua...

Страница 142: ...l specifications The following functions of the Otocheck ABR are deemed essential performance and were tested for immunity in compliance with IEC60601 1 2 a The collection of Auditory Brainstem Respon...

Страница 143: ...trengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip...

Страница 144: ...r radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey...

Страница 145: ...5 3 5 7 10 11 11 22 100 35 35 70 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to t...

Страница 146: ...e sound field is generated by the probe sealed in the ear canal by its tip d e Calibration cavity and measurement type For the purposes of EN60645 3 calibration was performed in an occluded ear canal...

Страница 147: ...eck during stimulus setup rectangular stimulus If this stimulus was replaced by the reference stimulus of the same amplitude the level generated in a IEC 60711 ear simulator would be 90dB 6 1dB 3 0dB...

Страница 148: ...planations Training required Class II Type BF DC Caution USB 1 1 When discarded the item must be sent to separate collection facilities for recovery and recycling Probe socket Battery charging indicat...

Страница 149: ...eck ABR User Manual 149 Index Refer to operating instructions Otodynamics factory address Product catalogue number Product date of manufacture Product serial number Bluetooth enabled RF transmitter SN...

Страница 150: ...e LEDs 25 Bluetooth 84 Brightness 76 C Calendar 137 Cavity test 105 Certification 18 Changing probe coupler tubes 110 Charging the Otoport 119 Charging the printer 93 Chirp stimulus 72 Choice bars 24...

Страница 151: ...character table 23 Fsp 48 G Good Stimulus 16 H Hard reset 25 Hardware options 137 Hardware processing and storage 137 High EEG noise 53 High impedance 53 High mains noise 53 I Impedance check 40 Impe...

Страница 152: ...cks 99 Quality tests 99 Query 102 R Records 62 Regulatory marks 18 RFID scanning 96 S Save 56 Scanner 17 Scanning 95 Select ear 57 Service 128 Skin preparation 33 Standby 117 Stimulus adjustment 45 St...

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